FDA Adverse Event
Summary report: N
PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM
MDR report key: 3250391
·
Received July 22, 2013
Report
- Report Number
- 9617613-2013-00589
- Date Received
- July 22, 2013
- Report Date
- July 6, 2013
- Manufacturer
- COVIDIEN, FORMERLY TISSUE
- Product Code
- FTL
- PMA / PMN Number
- K992556
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TRACKING NUMBER (B)(4). COVIDIEN IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (IMPORTER).
Description of Event or Problem · 1
PROCEDURE: STRESS UI/PELVIC ORGAN PROLAPSE. ACCORDING TO THE REPORTER: THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. TVT DEVICE WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341703 | PELVICOL ACELLULAR COLLAGEN MATRIX 4X7CM | PELVICOL MESH | FTL | COVIDIEN, FORMERLY TISSUE | 03B10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PELVICOL ACELLULAR COLLEGEN MATRIX| PRODUCT# 482047, LOT# 03B10| PELVICOL ACELLULAR COLLEGEN MATRIX| PRODUCT# 482047, LOT# 03B10 |